: Foremost Lactose Monohydrate, NF

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1 Foremost Lactose Monohydrate, NF Revision date: 01/22/2013 : Version: 1.1 SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1. Product identifier Product form : Substance Trade name : Foremost Lactose Monohydrate, NF Chemical name : Lactose Monohydrate CAS No. : Product code : WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL ; WL Formula : C 12 H 22 O 11.H 2 O Synonyms : Milk Sugar Product group : Trade product Other means of identification : Foremost NF Fast Flo Lactose 1.2. Relevant identified uses of the substance or mixture and uses advised against Use of the substance/preparation 1.3. Details of the supplier of the safety data sheet Foremost Farms USA Foremost Drive Rothschild, WI T (USA) 8:00 5:00 PM CST : Excipient material used in pharmaceutical applications For more information contact: Emergency telephone number Emergency number : (USA) 8:00 5:00 PM CST SECTION 2: Hazards identification 2.1. Classification of the substance or mixture GHS US classification Combustible Dust 2.2. Label elements GHS US labelling Hazard pictograms (GHS US) : None 01/22/2013 EN (English) 1/7

2 Signal word (GHS US) Hazard statements (GHS US) Precautionary statements (GHS US) 2.3. Other hazards : Warning : May form combustible dust concentrations in air. : None SECTION 3: Composition/information on ingredients 3.1. Substances Substance type : Mono constituent Name : Foremost Lactose Monohydrate, NF CAS No. : EC no : EC index no : Name Product identifier % GHS US classification Lactose, monohydrate (CAS No.) Combustible Dust 3.2. Mixtures Not applicable SECTION 4: First aid measures 4.1. Description of first aid measures First aid measures general First aid measures after inhalation First aid measures after skin contact First aid measures after eye contact First aid measures after ingestion : If medical advice is needed, have product container or label at hand. : If inhaled, remove to fresh air and keep at rest in a position comfortable for breathing. If not breathing, give artificial respiration. Obtain medical attention if breathing difficulty persists. : Rinse with plenty of water. : Rinse with water while holding eyelids open. If eye irritation persists: Get medical advice and attention. : Do not induce vomiting. Seek medical attention if a large amount is swallowed Most important symptoms and effects, both acute and delayed Symptoms/injuries Symptoms/injuries after inhalation Symptoms/injuries after skin contact Symptoms/injuries after eye contact Symptoms/injuries after ingestion Chronic symptoms : Prolonged contact with large amounts of dust may cause mechanical irritation. : None under normal use. Overexposure may be irritating to the respiratory system. : None under normal use. Prolonged contact with a large amount of dust may cause mechanical irritation. : None under normal use. Prolonged contact with large amounts of dust may cause mechanical irritation. : None under normal use. : Prolonged inhalation of dust may cause respiratory irritation Indication of any immediate medical attention and special treatment needed 01/22/2013 EN (English) 2/7

3 SECTION 5: Firefighting measures 5.1. Extinguishing media Suitable extinguishing media Unsuitable extinguishing media : Not considered flammable but will burn at high temperatures. Use extinguishing media appropriate for surrounding fire. : None known Special hazards arising from the substance or mixture Fire hazard Explosion hazard Reactivity : Combustible Dust. Dust explosion hazard in air. : Dust clouds can be explosive. Avoid dust clouds in combination with static electricity. : Stable at ambient temperature and under normal conditions of use Advice for firefighters Firefighting instructions Protection during firefighting : Do not breathe fumes from fires or vapours from decomposition. : Use normal individual fire protective equipment. SECTION 6: Accidental release measures 6.1. Personal precautions, protective equipment and emergency procedures General measures : Handle in accordance with good industrial hygiene and safety practice. Good housekeeping is needed during storage, transfer, handling, and use of this material to avoid excessive dust accumulation For non emergency personnel Protective equipment Emergency procedures For emergency responders Protective equipment Emergency procedures : Not required for normal conditions of use. : Collect as any solid. Ventilate area. : If possible, stop flow of product. : Contain and collect as any solid. Ventilate area Environmental precautions 6.3. Methods and material for containment and cleaning up For containment Methods for cleaning up 6.4. Reference to other sections SECTION 7: Handling and storage 7.1. Precautions for safe handling Precautions for safe handling Hygiene measures : Contain and collect as any solid. : Avoid generation of dust during clean up of spills. : Handle in accordance with good industrial hygiene and safety procedures. Good housekeeping is needed during storage, transfer, handling, and use of this material to avoid excessive dust accumulation. Take precautionary measures against static discharge. : Handle in accordance with good industrial hygiene and safety procedures. Emergency eye wash fountains should be available in the immediate vicinity of any potential exposure. 01/22/2013 EN (English) 3/7

4 7.2. Conditions for safe storage, including any incompatibilities Storage conditions 7.3. Specific end use(s) Excipient material used in pharmaceutical applications SECTION 8: Exposure controls/personal protection 8.1. Control parameters : Protect from moisture. Store in a dry, cool place. Keep container tightly closed Exposure controls Appropriate engineering controls Personal protective equipment : Avoid dust production. Ensure adequate ventilation, especially in confined areas. Take precautionary measures against static discharges. : Safety glasses. Eye protection Skin and body protection Respiratory protection Environmental exposure controls Consumer exposure controls : Safety glasses. : Wear suitable protective clothing. : Not required for normal conditions of use. In case of inadequate ventilation wear respiratory protection. : Ensure adequate ventilation, especially in confined areas. Emergency eye wash fountains should be available in the immediate vicinity of any potential exposure. : Wear recommended personal protective equipment. SECTION 9: Physical and chemical properties 9.1. Information on basic physical and chemical properties Physical state : Solid Appearance : Powder Color Odor Odor threshold ph : White : Slight : Slightly acidic Concentration of ph solution : 10 % Relative evaporation rate (butyl acetate=1) Melting point : 202 C (396 F) 01/22/2013 EN (English) 4/7

5 Freezing point Boiling point Flash point Self ignition temperature Decomposition temperature Flammability (solid, gas) Vapor pressure Relative vapor density at 20 C Relative density Solubility Log Pow Log Kow Viscosity, kinematic Viscosity, dynamic Explosive properties Oxidising properties Explosive limits : C (680 F 878 F) : Soluble. Water: 21.6 g/100ml at 25 C (77 F) : See range below. : None known : g/m³ 9.2. Other information SECTION 10: Stability and reactivity Reactivity Stable at ambient temperature and under normal conditions of use Chemical stability Stable at standard temperature and pressure Possibility of hazardous reactions Hazardous polymerization will not occur Conditions to avoid Use good housekeeping practices during storage, transfer, handling, to avoid excessive dust accumulation. 01/22/2013 EN (English) 5/7

6 10.5. Incompatible materials Hazardous decomposition products Under conditions of fire this material may produce: Carbon dioxide. Carbon monoxide. SECTION 11: Toxicological information Information on toxicological effects Acute toxicity Skin corrosion/irritation Serious eye damage/irritation Respiratory or skin sensitisation Germ cell mutagenicity Carcinogenicity Reproductive toxicity Specific target organ toxicity (single exposure) Specific target organ toxicity (repeated exposure) Aspiration hazard SECTION 12: Ecological information Toxicity Persistence and degradability Foremost Lactose Monohydrate, NF ( ) Persistence and degradability Product is biodegradable Bioaccumulative potential Mobility in soil Other adverse effects SECTION 13: Disposal considerations Waste treatment methods Sewage disposal recommendations Waste disposal recommendations : Do not dispose of waste into sewer. : Dispose of waste material in accordance with all local, regional, national, and international regulations. 01/22/2013 EN (English) 6/7

7 SECTION 14: Transport information In accordance with DOT / TDG / ADR / RID / ADNR / IMDG / ICAO / IATA UN number No dangerous good in sense of transport regulations UN proper shipping name Not applicable 14.2 Additional information Other information : No supplementary information available. Overland transport Transport by sea Air transport SECTION 15: Regulatory information US Federal regulations 15.2 National regulations US State regulations 16: Other information SDS US (GHS HazCom 2012) The information contained herein is based on our state of knowledge at the above specified date. It refers solely to the product indicated and constitutes no guarantee of particular quality. It is the duty of the user to ensure that this information is appropriate and complete with respect to the specific use intended. 01/22/2013 EN (English) 7/7

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